FDA Adverse Event
Other
Summary report: N
GBAT GUIDE ROD, DENTAL SHAFT
MDR report key: 1620167
·
Received March 1, 2010
Report
- Report Number
- 8010177-2010-00142
- Event Type
- Other
- Date Received
- March 1, 2010
- Date of Event
- February 4, 2010
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- DZE
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT INVESTIGATION WAS INITIATED BUT IS NOT YET COMPLETE.
Description of Event or Problem · 1
THE ROD IS TOO THICK TO FIT INTO THE HANDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GBAT GUIDE ROD, DENTAL SHAFT | IMPLANT | DZE | STRYKER OSTEOSYNTHESIS FREIBURG | NA | Z7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |